The most consequential date in cosmetics regulations for the USA and EU in 2026 is 31 July, and it is not an American one. That is the last day a new cosmetic product can be placed on the EU market without the expanded fragrance allergen labeling. From 1 August, it is required. Meanwhile in the United States, the two MoCRA rules everyone braced for have both slipped, one of them by years.
For soap specifically there is a wrinkle that decides everything else: whether your product is legally soap or legally a cosmetic. The answer differs by product, and it differs by country. Botanie manufactures genuine soap alongside cosmetic cleansers like shampoo bars, so sorting out which side of that line a product sits on is a conversation we have constantly.
Also Read
- Cosmetic Labeling Requirements
- Do You Need a License to Sell Soap?
- What It Means to Be Organic: USDA Organic Standards Explained
Short Version
MoCRA facility registration and product listing have been enforced in the US since July 2024, with facilities renewing every two years and product listings requiring annual updates, and businesses averaging under about $1 million in yearly cosmetic sales are exempt from both plus future GMP rules. Genuine true soap sold only as soap stays under the Consumer Product Safety Commission rather than the FDA, while shampoo bars, liquid cleansers, and any bar making cosmetic claims are cosmetics that do fall under MoCRA.
The two big pending MoCRA rules have both been pushed back: fragrance allergen labeling is now projected for a proposed rule in November 2026, and cosmetic Good Manufacturing Practices has been reclassified as a long-term action projected for November 2027. In the EU, expanded fragrance allergen labeling becomes mandatory for new products from 1 August 2026, and a REACH microplastics phase-out reaches rinse-off products in October 2027, though the microbead ban already took effect in 2023. The EU treats all soap as a cosmetic, so exporters face notification, a Responsible Person, and a formal safety assessment regardless of what they make.
Key Points
- Registration is biennial, listing is annual. Facility registrations renew every two years, but product listing updates are due annually. These are two separate clocks and missing the second one is the most common error.
- The system is now genuinely large. As of 31 March 2026 the FDA held 15,309 active facility registrations and 1,102,092 active product listings.
- The small business exemption covers more than people think. Under $1 million in average annual cosmetic sales exempts you from registration, listing, and GMP, though not from safety substantiation, labeling rules, or adverse event reporting.
- True soap is still outside FDA cosmetic jurisdiction. The exemption survived MoCRA intact, and it rests on a two-part regulatory test plus how you sell the product.
- Your marketing language sets your legal category. Call a bar moisturizing and it becomes a cosmetic. Call it antibacterial and it moves toward drug status.
- Both pending MoCRA rules have slipped. Fragrance allergen labeling missed a June 2024 statutory deadline and has still not been proposed. GMP is now a long-term action.
- The EU adds 56 allergens, bringing the total near 80. New products must comply from 1 August 2026, with existing stock allowed on shelves until 31 July 2028.
- The EU microbead ban is already in force. Abrasive microplastics have been prohibited since October 2023 with no transition period, which matters for exfoliating bars.
The US Picture: MoCRA Is Live, but Incomplete
The Modernization of Cosmetics Regulation Act gave the FDA real authority over cosmetics for the first time in decades. Two years into enforcement, the obligations that exist are firm and the ones everyone worried about are still theoretical.
What is actually in force
Facility registration and product listing have been enforced since 1 July 2024, following an FDA compliance policy that granted six months past the statutory December 2023 deadline. The FDA's registration and listing page covers the current requirements, and in February 2026 the agency added registration status fields and automated renewal reminders to its Cosmetics Direct portal, timed to the first wave of biennial renewals coming due.
The detail that trips brands up: facility registration renews biennially, but the statute separately requires that product listings be updated annually. Brands that treat the two-year clock as covering everything fall out of compliance on listings without noticing.
Beyond registration, cosmetics require a responsible person named on the label, safety substantiation, adverse event reporting, and recordkeeping. Those apply now.
What has not arrived
The fragrance allergen labeling rule has not been proposed. MoCRA required a notice of proposed rulemaking by 29 June 2024. That deadline passed, and the current Unified Agenda projects November 2026 for a proposed rule, which puts a final rule and any compliance date years further out.
Cosmetic Good Manufacturing Practices has moved further still. It is now classified as a long-term action with a projected proposed rule in November 2027, after missing a December 2024 statutory deadline. Nothing binding exists yet.
Two other items closed out recently. The FDA published its report on PFAS in cosmetics on 29 December 2025, identifying 51 PFAS across 1,744 formulations and concluding that toxicological data was incomplete for most of them. No federal ban followed, though several states restrict PFAS independently. And the proposed talc asbestos testing rule was withdrawn on 28 November 2025 after comments raised technical objections, with the FDA stating it will issue a replacement.
The small business exemption
Responsible persons and facility operators averaging under $1 million in US cosmetic sales over the prior three years are exempt from both registration and listing and the future GMP requirements. That second half matters more than it gets credit for: a small maker who never registers will also never be subject to GMP.
The exemption does not apply to products that routinely contact the mucous membrane of the eye, injected products, products for internal use, or products intended to alter appearance for more than 24 hours where the consumer does not customarily remove them. It also does not excuse safety substantiation, correct labeling, or serious adverse event reporting. Those obligations survive the exemption entirely.
Building a line and unsure which category it lands in? Formulation and compliance decisions are cheaper to make together than sequentially. Talk to Botanie about your product before you finalize the formula.
The True Soap Line, and Why It Still Matters
This is the exemption that keeps a great many soap makers outside the FDA entirely, and it is narrower than people assume.
The governing regulation is 21 CFR 701.20, which sets two conditions: the bulk of the product's non-volatile matter must consist of alkali salts of fatty acids, with the product's detergent properties due to those compounds, and the product must be labeled, sold, and represented only as soap. The FDA's soap FAQ splits that into the familiar three-part test and confirms the consequence: products meeting the definition are regulated by the Consumer Product Safety Commission, not by the FDA.
Cross any part of the line and the product becomes a cosmetic. A syndet bar cleans through synthetic detergents rather than fatty acid salts, so it is a cosmetic regardless of how it is marketed. A bar that cleans through true soap but is sold as moisturizing or deodorizing has failed the "sold only as soap" condition, so it is also a cosmetic. An antibacterial or acne claim pushes further, toward drug status.
Put practically: a plain cold process bar sold as soap is CPSC soap. A shampoo bar, a body wash, or a bar whose packaging promises skin benefits is a cosmetic under MoCRA. We covered the underlying question in more depth in is soap a cosmetic, and the takeaway is simple: your copywriter can change your regulatory category without telling you.
The EU Picture: Allergens Now, Microplastics Next
One framework, no soap exemption
Regulation (EC) No 1223/2009 governs every cosmetic sold in the EU, and it explicitly names toilet soaps and deodorant soaps as cosmetic products in its recitals. There is no European analogue to the FDA's true soap exemption. That is the single sharpest difference between the two regimes.
Selling into the EU therefore requires a Responsible Person established in the Union under Article 4, a safety assessment and Cosmetic Product Safety Report before market entry under Article 10, a Product Information File retained for ten years after the last batch under Article 11, and notification through the Cosmetic Product Notification Portal under Article 13.
Fragrance allergens, required from 1 August 2026
Regulation (EU) 2023/1545 expands individual fragrance allergen labeling considerably. Twenty-four allergens already required individual labeling. The Scientific Committee on Consumer Safety identified 56 additional substances that have clearly caused allergies in humans, bringing the labeled total to roughly 80.
The thresholds are 0.001 percent in leave-on products and 0.01 percent in rinse-off products. Non-compliant products may be placed on the Union market until 31 July 2026 and made available until 31 July 2028, which means existing stock has a two-year runway but anything new does not.
Essential oils are where this lands hardest for natural brands, since several of the newly listed substances occur naturally in common oils rather than being added as isolated fragrance chemicals. If your formula relies on essential oils, the labeling work is real even though nothing about your ingredients changed. Our team has written before about why the word fragrance stopped being a simple one, and this regulation is the formal version of that argument.
Microplastics, already partly in force
Regulation (EU) 2023/2055 phases out intentionally added synthetic polymer microparticles under REACH. The transition dates are 17 October 2027 for rinse-off cosmetics, 17 October 2029 for leave-on, and 17 October 2035 for lip, nail, and makeup products.
The provision most likely to affect a soap maker is the one with no transition at all. Microplastics used as an abrasive, meaning anything intended to exfoliate, polish, or clean, were carved out of every transition period and have been prohibited since the regulation applied on 17 October 2023. If you sell an exfoliating bar into the EU with synthetic polymer beads, that is already non-compliant.
The UK diverged
Great Britain now runs its own regime under the retained regulation as amended for EU exit. Per the Office for Product Safety and Standards guidance, it requires a Responsible Person with an actual UK address, and mail forwarding addresses and PO boxes are explicitly rejected. Notification goes through the Submit Cosmetic Product Notifications service rather than the CPNP, the Product Information File must be held in English for ten years after the last batch, and the safety assessor must hold a university degree in pharmacy, toxicology, medicine, or a similar discipline.
Northern Ireland is the exception: EU Regulation 1223/2009 still applies there, the Responsible Person must be established in Northern Ireland or the EU, and notification goes to the CPNP.
Manufacturing with documented formulations makes compliance easier Safety substantiation and Product Information Files both depend on knowing exactly what is in the bar. See how Botanie documents every formula.
US vs EU at a Glance
What To Do Based on What You Sell
If you sell true soap in the US
You are with the CPSC. The work is keeping the exemption: audit your packaging and website copy for claims that would recategorize the product, and follow CPSC labeling along with the Fair Packaging and Labeling Act. Our overview of soap labeling requirements covers the practical side.
If you sell shampoo bars, liquid cleansers, or claim-making bars
These are cosmetics under MoCRA. Determine whether you exceed the $1 million threshold. If you do, register the facility, list the products, name a responsible person on the label, and set a calendar reminder for the annual listing update separately from the biennial registration renewal. If you do not exceed it, you still owe safety substantiation, correct labeling, and adverse event reporting.
If you export to the EU or UK
Appoint a Responsible Person in each jurisdiction separately, notify through CPNP or SCPN as applicable, build a Product Information File with a safety assessment by a qualified assessor, and check your fragrance disclosures against the expanded allergen list now rather than at the 2028 sell-through date.
6 Compliance Checkpoints for Any Soap Brand in 2026
Run through these before your next production order.
- Know your category before you write your copy. True soap, cosmetic, and drug are decided by claims as much as by chemistry.
- Track two clocks in the US. Facility registration every two years, product listing updates every year.
- Do not wait for the FDA allergen rule. It has not been proposed, and aligning to the EU list now is the practical hedge.
- Check your essential oils against the EU's 56 new allergens. Natural does not mean exempt.
- Audit exfoliants immediately if you sell into the EU. The microbead ban has been in force since 2023.
- Keep formulation records you could hand to an assessor. Every compliance path in both regimes runs through documentation.
FAQ
Does my soap need FDA registration?
Only if it is legally a cosmetic. A true soap sold only as soap is regulated by the CPSC and sits outside MoCRA. A shampoo bar, liquid cleanser, or claim-making bar is a cosmetic and may require registration depending on your sales volume.
What is the MoCRA small business exemption?
Businesses averaging under $1 million in annual US cosmetic sales over the prior three years are exempt from facility registration, product listing, and future GMP requirements. Certain product types are excluded from the exemption, and it never covers safety substantiation, labeling, or adverse event reporting.
What changes in the EU on 1 August 2026?
31 July 2026 is the last day a non-compliant product may be placed on the EU market. From 1 August, every new cosmetic product must carry the expanded fragrance allergen labeling required by Regulation 2023/1545. Products already on the market have until 31 July 2028 to comply or be withdrawn.
Has the FDA published its fragrance allergen rule?
No. The statutory deadline of 29 June 2024 was missed, and the FDA currently projects a proposed rule in November 2026. A final rule with a compliance date would follow considerably later.
How Botanie Supports Compliance-Minded Brands
Botanie makes genuine cold process bar soap, true liquid soap, and syndet shampoo bars, which means partners know precisely which regulatory category each product occupies before they write a word of packaging copy. That clarity matters more than it sounds when the categories are decided by claims.
The certifications behind that come with paperwork attached. Botanie has held USDA National Organic Program certification through Oregon Tilth since 2008, along with Leaping Bunny certification from the same year. Documented formulations give brands the ingredient records that safety substantiation and Product Information Files both depend on.
One caveat. Botanie is a manufacturer, not a regulatory consultant, and brands remain responsible for confirming their own obligations. What a manufacturer can do is make the path shorter, and starting from real soap with a documented ingredient list does exactly that.
Conclusion
The regulatory picture in 2026 is genuinely in motion, with an EU deadline arriving this week and two American rules that keep receding. Underneath the movement, the first question has not changed: is your product soap or a cosmetic, and does your own marketing agree with your answer?
Get that right and most of the rest follows. Get it wrong and you can find yourself subject to a framework you never planned for, on the strength of a single word on a label.
Build your line with a manufacturer that documents every bar Botanie has spent more than 20 years making all-natural soap for 500+ brand partners, with formulation records that hold up to scrutiny. Start a conversation about your project.